Latest news with #FosterCity
Yahoo
19-06-2025
- Automotive
- Yahoo
Zoox unveils US robotaxi production facility
Zoox, an Amazon-backed company has inaugurated its first serial production facility for purpose-built robotaxis in the US, signalling a significant step in the company's expansion plans. The facility, located in Hayward, California, spans 220,000ft2 and is set to support Zoox's growth and robotaxi services across multiple markets. The new facility represents a pivotal moment for Zoox, being the second vehicle production site in the Bay Area. It complements the existing Fremont facility, which now focuses on the assembly of the Zoox testing fleet and sensor pod configuration. At full capacity, the Hayward site can assemble over 10,000 robotaxis annually, with production numbers set to align with the commercial service's demand. The Hayward facility is a hub for various operations, including robotaxi engineering, software and hardware integration, assembly, component storage, and shipping. It also houses the essential end-of-line testing before the robotaxis are deployed. This state-of-the-art facility not only showcases Zoox's values but also fosters close collaboration between engineers and other teams due to its proximity to the Foster City headquarters. Zoox's approach to owning, operating, and assembling its robotaxis provides the company with comprehensive oversight of the entire production process. This control allows Zoox to adjust production based on market demand and expansion plans. The facility's design and equipment are future-proof, ready to accommodate advances in robotaxi design. Despite the focus on autonomous robots, the human workforce remains integral to the manufacturing process at Zoox. Robots perform precision tasks, such as applying adhesive for glass installation, while the rest of the assembly is carried out manually. The facility is expected to create hundreds of jobs in the San Francisco Bay Area, with roles for operators, logistics personnel, and assembly specialists set to increase as the operation scales up. "Zoox unveils US robotaxi production facility" was originally created and published by Just Auto, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
News24
19-06-2025
- Health
- News24
Twice-a-year R500k HIV prevention shot wins US approval
Gilead Sciences said it won US approval for a drug to prevent HIV that only has to be given twice a year, making it a convenient new way to ward off infection in a wide range of people. In two big international studies published last year, the medicine demonstrated a powerful ability to avert HIV infection. With no vaccine on the horizon, the ultra-long acting shot has been hailed by activists as perhaps the best tool the world has so far to wipe out the virus. The medicine will be marketed as Yeztugo, Gilead said, and will have a list price of $28 218 (R509 000) per year. That compares to a list price of about $26 400 per year for Descovy, the company's daily pill for HIV prevention. Shares of Gilead briefly jumped as much as 3.5%, their biggest gain in almost a month. The stock had risen 17% this year through Tuesday, outperforming a 2% increase in the S&P 500 index. Even as it works to make the drug a bestseller in rich countries like the US, the Foster City, California-based company will face great pressure to rapidly roll it out for poor and middle income countries that have been hit hard by HIV. 'This is a milestone moment in the decades-long fight against HIV,' Gilead Chief Executive Officer Daniel O'Day said in an emailed statement. 'We now have a way to end the HIV epidemic.' The approval and rollout of the drug will being closely watched by Wall Street, which is hoping it will provide a new source of growth to turbocharge Gilead's mature portfolio of pills for HIV and hepatitis C. It's expected to surpass $4 billion in annual sales by 2031, according to analysts surveyed by Bloomberg. It will compete with Apretude, a prevention shot from ViiV Healthcare, majority-owned by GSK Plc, that's given every other month. While the incidence of HIV has declined since its peak in the 1990s, some 1.3 million people are infected with the virus each year. Some of the highest rates of new cases occur in various countries in Africa. And while daily prevention pills work, they have downsides. People can forget to take them. Others may not want to get them because of the stigma surrounding HIV, or because they worry the pill bottle may inadvertently divulge their high-risk status. Gilead has filed for approval in numerous places, including South Africa, Brazil, Australia, Canada, the European Union, and the EU Medicines For All programme, which helps speed the review of drugs that will be used in developing countries. In one large international trial published last November in men and transgender people, the drug prevented all but two HIV cases among 2 180 people given it, a rate 96% lower than the background incidence level in that population. It was also superior to the company's old HIV prevention pill Truvada. And in June, Gilead said a trial of the shot in women and adolescent girls in Africa prevented 100% of HIV cases, a result the company said was unprecedented. Side effects include injection site reactions, which caused 1.2% of people in one study to stop taking it. Gilead already sells the same drug, lenacapavir, as a treatment for people with multidrug-resistant HIV under the brand Sunlenca.
Yahoo
18-06-2025
- Health
- Yahoo
Yeztugo® (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection
– Approval Based on Phase 3 PURPOSE 1 and PURPOSE 2 Data that Showed ≥99.9% of Participants Remained HIV Negative on Twice-Yearly Injectable Yeztugo – – Yeztugo, Nearly 20 Years in the Making, Represents a Major Breakthrough in the Fight Against HIV – FOSTER CITY, Calif., June 18, 2025--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir)—the company's injectable HIV-1 capsid inhibitor—as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the United States for people who need or want PrEP. Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative. "This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," said Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences. "This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life's work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality." The first PrEP medication, which was also developed by Gilead, was approved in the U.S. in 2012. However, data from the Centers for Disease Control and Prevention (CDC) show that, in 2022 (the most recent year with available data), only about 1 in 3 (36%) people in the U.S. who met the CDC's eligibility criteria for PrEP were prescribed a form of PrEP. CDC data show that all populations in the U.S. are not yet using PrEP at rates that could end transmission of the virus at the population level, with particular gaps for women, Black/African American and Hispanic/Latino people, and people in the U.S. South. Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options—by both healthcare providers and consumers—contribute to this low uptake of PrEP across multiple populations. The potential impact of this limited uptake, adherence and access is underscored by the fact that, in 2023, more than 100 people were diagnosed with HIV every day in the U.S. "Yeztugo could be the transformative PrEP option we've been waiting for—offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic," said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta. "A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing." FDA approval of Yeztugo is supported by high efficacy and demonstrated safety data in two clinical trials The FDA approval of Gilead's New Drug Applications (NDAs) for Yeztugo was supported by data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead. In the PURPOSE 1 trial (NCT04994509), data at the primary analysis showed twice-yearly subcutaneous Yeztugo demonstrated zero HIV infections among 2,134 participants in the Yeztugo group, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in cisgender women in sub-Saharan Africa. In the PURPOSE 2 trial (NCT04925752), there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous Yeztugo group, demonstrating 99.9% of participants in the Yeztugo group did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people. In both trials, Yeztugo also demonstrated superiority of prevention of HIV infections when compared with background HIV incidence (bHIV) and was generally well-tolerated, with no significant or new safety concerns identified. Data from both trials were published in The New England Journal of Medicine and, based in part on the trial results, in December 2024 the journal Science named lenacapavir its 2024 "Breakthrough of the Year." Yeztugo received FDA approval under Priority Review. Additionally, in October 2024, Yeztugo was granted Breakthrough Therapy Designation, which is intended to expedite the development and review of new drugs that may demonstrate substantial improvement over available therapy. Gilead's U.S. access strategy for Yeztugo is designed to enable broad uptake and availability for individuals with and without insurance coverage In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo. Additionally, for eligible commercially insured individuals with commercial insurance, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars. Gilead is also committed to helping to ensure that people without insurance in the U.S. will be able to benefit from Yeztugo. For those who are eligible, Gilead's Advancing Access medication assistance program will provide Yeztugo free of charge. Additional regulatory filings are underway in countries around the world Outside of the U.S., Gilead is executing an access strategy, informed by global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review, approval of and access to twice-yearly lenacapavir for PrEP. Gilead has submitted a marketing authorization application (MAA) and EU-Medicines for all (EU-M4all) application with the European Medicines Agency (EMA), both of which the EMA has validated and will review under an accelerated assessment timeline. Gilead has also filed for regulatory approval for twice-yearly lenacapavir for PrEP with authorities in Australia, Brazil, Canada and South Africa. Additionally, now that Yeztugo has received FDA approval, Gilead is preparing additional filings in countries that rely on FDA approval for regulatory submission, including Argentina, Mexico and Peru. Gilead will continue to share updates on additional regulatory filings. Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the United States. There is currently no cure for HIV or AIDS. Please see below for the U.S. Indication and Important Safety Information for Yeztugo, including Boxed Warning. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals. Lenacapavir is also approved in the United States to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg who are at risk of HIV acquisition. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." U.S. Indication for Yeztugo Yeztugo (lenacapavir) injection, 463.5 mg/1.5 mL, is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents (>35kg) who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating Yeztugo. U.S. Important Safety Information for Yeztugo BOXED WARNING: RISK OF DRUG RESISTANCE WITH USE OF YEZTUGO IN UNDIAGNOSED HIV-1 INFECTION Individuals must be tested for HIV-1 infection prior to initiating Yeztugo, and with each subsequent injection of Yeztugo, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of Yeztugo by individuals with undiagnosed HIV-1 infection. Do not initiate Yeztugo unless negative infection status is confirmed. Individuals who acquire HIV-1 while receiving Yeztugo must transition to a complete HIV-1 treatment regimen. Contraindications Yeztugo is contraindicated in individuals with unknown or positive HIV-1 status. Warnings and precautions Comprehensive risk management: Use Yeztugo to reduce the risk of HIV-1 acquisition as part of a comprehensive prevention strategy including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). HIV-1 acquisition risk includes behavioral, biological, or epidemiologic factors including, but not limited to, condomless sex, past or present STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high-prevalence area or network. Counsel individuals on the use of other prevention methods to help reduce their risk. Use Yeztugo only in individuals confirmed to be HIV-1 negative. Evaluate for current or recent signs or symptoms consistent with HIV-1 infection. Confirm HIV-1 negative status prior to initiating, prior to each subsequent injection, and as clinically appropriate. Potential risk of resistance: There is a potential risk of developing resistance to Yeztugo if an individual acquires HIV-1 before or when receiving Yeztugo, or following discontinuation. HIV- 1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection taking only Yeztugo, because Yeztugo alone is not a complete regimen for HIV-1 treatment. To minimize this risk, it is essential to test before each injection and additionally as clinically appropriate. Individuals confirmed to have HIV-1 must immediately begin a complete HIV-1 treatment regimen. Alternative forms of PrEP should be considered after discontinuation of Yeztugo for those who are at continuing risk of HIV-1 acquisition and should be initiated within 28 weeks of the last Yeztugo injection. Long-acting properties and potential associated risks: Residual concentrations of Yeztugo may remain in systemic circulation for up to 12 months or longer after the last injection. Select individuals who agree to the required injection dosing schedule because nonadherence or missed doses could lead to HIV-1 acquisition and development of resistance. Serious injection site reactions: Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. Only administer Yeztugo subcutaneously. Adverse reactions Most common adverse reactions (≥5%) in Yeztugo clinical trials were injection site reactions, headache, and nausea. Drug interactions Strong or moderate CYP3A inducers may significantly decrease Yeztugo concentrations. Dosage modifications are recommended when initiating these inducers. It is not recommended to use Yeztugo with combined P-gp, UGT1A1, and strong CYP3A inhibitors. Coadministration of Yeztugo with sensitive substrates of CYP3A or P-gp may increase their concentrations and result in the increased risk of their adverse events. Yeztugo may increase the exposure of drugs primarily metabolized by CYP3A initiated within 9 months after the last injection of Yeztugo. Dosage and administration HIV screening: Test for HIV-1 infection prior to initiating, prior to each subsequent injection, and as clinically appropriate using an approved or cleared test for the diagnosis of acute or primary HIV-1 infection. Dosage: Initiation dosing (injections and tablets) followed by once-every-6-months continuation injection dosing. Tablets may be taken with or without food. Initiation: Day 1: 927 mg by subcutaneous injection (2 x 1.5-mL injections) and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally. Continuation: 927 mg by subcutaneous injection every 6 months (26 weeks) from date of last injection ±2 weeks. Anticipated delayed injections: If scheduled 6-month injection is anticipated to be delayed by more than 2 weeks, Yeztugo tablets may be taken on an interim basis (for up to 6 months) until injections resume. Dosage is 300 mg orally (1 x 300-mg tablet) once every 7 days. Resume continuation injections within 7 days of the last oral dose. Missed injections: If more than 28 weeks have elapsed since the last injection and Yeztugo tablets have not been taken, restart with initiation dosing if clinically appropriate. Dosage modifications of Yeztugo are recommended when initiating with strong or moderate CYP3A inducers. Consult the full Prescribing Information for recommendations. About Gilead HIV For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 13 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Yeztugo (lenacapavir) (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; the risk that physicians may not see the benefits of prescribing Yeztugo for PrEP; Gilead's ability to effectively manage the access strategy relating to lenacapavir, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. U.S. full Prescribing Information for Truvada and Yeztugo, including Boxed Warning, are available at Advancing Access, Truvada, Truvada for PrEP, Yeztugo, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company's website at follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). View source version on Contacts Ashleigh Koss, Mediapublic_affairs@ Jacquie Ross, Investorsinvestor_relations@ Sign in to access your portfolio
TechCrunch
18-06-2025
- Automotive
- TechCrunch
Amazon's Zoox opens its first major robotaxi production facility
Amazon-owned autonomous vehicle company Zoox has opened its first full-fledged production facility, where it expects to be able to one day build 10,000 robotaxis per year. The facility marks the latest step in Zoox's evolution out of the development phase. The company is currently testing vehicles in multiple U.S. cities, and offering rides to employees in Las Vegas and San Francisco. Public access is expected to begin with an early-rider program in 2026. The 220,000-square-foot factory is located in Hayward, California near its Foster City headquarters. This is Zoox's second production facility in the Bay Area, adding to the assembly warehouse in nearby Fremont. Zoox says the new factory will be used for engineering, software and hardware integration, assembly, storage, and testing. The Hayward production facility will assemble the custom-built Zoox robotaxis for multiple commercial markets, beginning with Las Vegas and then San Francisco. Zoox plans to roll out commercial robotaxi operations in Austin and Miami in the next few years. The company says the facility's 'unique layout and building equipment' will be able to adapt to different vehicle designs as its robotaxi lineup expands in the future. The facility will be operated by a mix of human workers and robots. Human workers will handle the bulk of the work, according to Zoox, which said robots will be used for specific tasks, such as applying adhesive for glass installation and transporting the robotaxi down the assembly line.
Fast Company
18-06-2025
- Health
- Fast Company
This company's drug could effectively end the HIV epidemic—but patients remember how it slow walked a past treatment
Four decades after the human immunodeficiency virus was first identified, the end of the epidemic could be in sight. Thanks to treatments and preventive medications, new infections worldwide have fallen dramatically, from 3.3 million at their peak in 1995 to 1.3 million in 2023. Now, with the arrival of a groundbreaking drug from Gilead Sciences, there's serious talk about bringing new cases down to zero. Foster City, California–based Gilead is already the leader in HIV prevention. Its daily oral pill Descovy accounts for about 40% of the U.S. market for pre-exposure drugs, known as PrEP (pre-exposure prophylaxis). Sales of the company's portfolio of drugs for HIV prevention and treatment reached $19.6 billion in 2024. Some 75% of the nearly 40 million people worldwide who live with HIV receive a Gilead-branded drug or a generic version, according to the company. But the twice-a-year injectable lenacapavir, which is on track for a June 19 approval as PrEP by the U.S. Food and Drug Administration, has the potential to be a game changer. The first study of lenacapavir to prevent HIV infections, which included more than 5,000 women, showed it to be 100% effective—the first Phase 3 HIV-prevention trial ever with zero infections. In a subsequent study of more than 3,000 men, transgender people, and nonbinary individuals who had sex with male partners, lenacapavir reduced new HIV infections by 96% compared to background incidence. 'A twice-yearly injection to prevent the infection could change everything,' says Gilead CEO Daniel O'Day, 'putting an end to the epidemic and all the health and economic challenges that come with it.' According to one estimate, lenacapavir could avert up to a third of HIV infections in eastern and southern Africa over 10 years, if priced affordably enough. Gilead has trumpeted plans for the rollout of lenacapavir in low- and middle-income countries.
